Abstract

3770 Background: A combination of OXA and FU is frequently used as 1st or 2nd line therapy for advanced CRC. Anyway, the optimal schedule for this drugs has not been defined. Methods: To identify the MTD of weekly OXA (60–70-80–90 mg/m2 d1,8,15) in combination with a fixed dose of FU CI (200mg/m2/die d1–21), at least 3 pts were treated at each dose level. Once identified the OXA recommended dose level (RDL), Leucovorin (LV; 20 mg/m2 d1,8,15) was added to the combination. Results: Since April 2000, 39 pts with progressive advanced CRC previously treated with fluoropyrimidines and Irinotecan (IRI) were accrued (males/females: 29/10; median age 67; ECOG PS 0/1/2: 10/24/5). Considering the first 2 cycles of treatment (2 months) no grade III-IV toxicity was observed up to 90 mg/m2/week of OXA (dose level 4). 3/6 pts treated at dose level 4 required a major change in the treatment program due to a dose limiting toxicity (DLT; asthenia, weight loss and unbearable peripheral sensory neuropathy) and OXA 90 mg/m2 +...

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